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NCT05332613 · ClinicalTrials.gov registry record · NA
Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease
A NA study of Non-alcoholic Fatty Liver Disease, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05332613: Recruiting NA study of Non-alcoholic Fatty Liver Disease, sponsored by Weill Medical College of Cornell University.
NCT05332613 is a NA study of Non-alcoholic Fatty Liver Disease that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 40 participants, below the 177-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05332613, a NA study of Non-alcoholic Fatty Liver Disease, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will assess the impact of time-restricted eating (8 hours of eating each day) with standard of care lifestyle recommendations (hypocaloric, Mediterranean diet and 30 minutes of exercise on at least 5 days/week) on the degree of fat in the liver as measured by magnetic resonance imaging.
Primary Outcome
Evaluate the percentage of patients with baseline MASLD (MRI-PDFF greater than or equal to 10%) who achieve clinically significant improvement in hepatic fat, as defined by greater than or equal to 30% reduction from baseline liver fat on MRI-PDFF, while adopting a time-restricted eating pattern (fasting 16 hours per day) along with standard of care management as compared to patients with only standard of care NAFLD management.
Conditions Studied
Interventions
- BEHAVIORAL SOC
- BEHAVIORAL TRE plus SOC
- BEHAVIORAL TRE
Study Locations (1)
New York
- Weill Cornell Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-04-27 |
| Est. Completion | 2030-12-31 |
| Phase | NA |
What NCT05332613 shows while recruiting
NCT05332613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 177-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 3 interventions - of which SOC is the first listed.
NCT05332613 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05332613 about?
NCT05332613 is a clinical study titled "Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease". This study will assess the impact of time-restricted eating (8 hours of eating each day) with standard of care lifestyle recommendations (hypocaloric, Mediterranean diet and 30 minutes of exercise on at least 5 days/week) on the degree of fat in the liver as measured by magnetic resonance imaging.
What is the current status of trial NCT05332613?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2022-04-27. Estimated completion is 2030-12-31.
What conditions does trial NCT05332613 study?
This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease.
What interventions are being tested in trial NCT05332613?
The interventions under investigation include: SOC (BEHAVIORAL), TRE plus SOC (BEHAVIORAL), TRE (BEHAVIORAL).
Who is sponsoring clinical trial NCT05332613?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05332613 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05332613's enrollment target sits among peer trials
40 40th of 57 higher than 15 of 57 other Non-alcoholic Fatty Liver Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-alcoholic Fatty Liver Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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